Senior Cdmo Project Manager
il y a 6 jours
As a Senior CDMO Project Manager, you lead, plan and manage several projects related to the development of pharmaceutical products (APIs and drug products).**Responsibilities**
- You drive a cross-functional team dedicated to new product development (R&D experts, industrialization, supply chain, quality control, regulatory affairs, quality assurance).
- You manage pro-actively the relationship with external customers and key sub-contractors.
- You manage projects according to the company governance from the initial phase (opportunity) to the validation and transfer to manufacturing. In particular, you will be in charge of
- Drafting and updating the project scope and planning based on market requirements and/or specific customer needs
- Building and coordinating a multidisciplinary project team
- Defining the required documentation and deliverables
- Monitoring regularly the project cost, risks, resource allocation and planning of deliverables
- Reporting on the progress to the project and management teams, and to the customer
- Drafting the contractual documents with customer and key subcontractors
- Assessing product and process risk analysis.
- You work and develop your project in compliance with safety and regulatory requirements.
- You participate in regulatory inspections, customer audits, or others as required.
**Profile**
- You have a Master or PhD degree in chemistry, pharmacy or equivalent through experience.
- You have a proven experience (at least 10 years) in the development and GMP manufacturing of drug substances or products.
- You have a strong experience in managing people and projects.
- The following aspects will be considered as an asset.
- Practical experience in the production of radiopharmaceuticals
- Experience in synthesis, characterization, stability testing or quality control of pharmaceutical products
- Some knowledge of compendial testing (according to Ph. Eur and USP)
- You have a strong communication skills in French and English (C1-C2 min.)
- You appreciate teamwork.
- You have excellent writing skills (French and English).
- You master MS Office.
- You are innovative, pragmatic and organized with a sense of priorities and rigor.
**Do you want to become a major player in the global fight against cancer?**
At Trasis, we give you the opportunity to work with cutting-edge technologies and to contribute to the improvement of cancer diagnosis and therapy techniques. Through your actions, you will have the opportunity to have a positive impact on the services provided to users and patients.
The opportunity to participate in building and improving processes in a growing company.
We offer a young and friendly work atmosphere, a flexible and dynamic environment.
- An attractive and flexible salary according to your experience and performance, with extra-legal benefits.
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